Cost‐effectiveness of blood donor screening for Babesia microti in endemic regions of the United States

Abstract

Background Babesia microti is the leading reported cause of red blood cell (RBC) transfusion-transmitted infection in the United States (US). Donor screening assays are in development. Study Design and Methods A decision analytic model estimated the cost-effectiveness of screening strategies for preventing transfusion-transmitted babesiosis (TTB) in a hypothetical cohort of transfusion recipients in Babesia-endemic areas of the US. Strategies included: (1) No screening, (2) Uniform Donor Health History Questionnaire (UDHQ), “status quo”, (3) Recipient risk-targeting using donor antibody (Ab) and polymerase chain reaction (PCR) screening, (4) Universal endemic donor Ab screening, (5) Universal endemic donor Ab and PCR screening. Outcome measures were TTB cases averted, costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios ($/QALY). We assumed a societal willingness to pay of $1 million/QALY based on screening for other transfusion-transmitted infections. Results Compared to no screening, the UDHQ avoids 0.02 TTB cases per 100,000 RBC transfusions at an incremental cost effectiveness ratio (ICER) of $160,000/QALY whereas recipient risk-targeted strategy using Ab/PCR avoids 1.62 TTB cases per 100,000 RBC transfusions at an ICER of $713,000/QALY compared to the UDHQ. Universal endemic Ab screening avoids 3.39 cases at an ICER of $760,000/QALY compared to the recipient-risk targeted strategy. Universal endemic Ab/PCR screening avoids 3.60 cases and has an ICER of $8.8 million/QALY compared to universal endemic Ab screening. Results are sensitive to blood donor Babesia prevalence, TTB transmission probability, screening test costs, risk and severity of TTB complications, and impact of babesiosis diagnosis on donor quality of life. Conclusion Antibody screening for Babesia in endemic regions is appropriate from an economic perspective based on the societal willingness to pay for preventing infectious threats to blood safety.

Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay

“…As an EIA in standard microplate format, it should be amenable to high-throughput processing and promises to meet cost-effectiveness criteria as set forth in recent analyses. 40 …”

Assessing the risk of Babesia to the United States blood supply using a risk‐based decision‐making approach: Report of AABB's Ad Hoc Babesia Policy Working Group (original report)

“…The economic impact assessment team noted that since 2014, three studies have been conducted on the cost effectiveness of B. microti screening with highly variable cost‐effectiveness results ranging from $54,000 to $83,000/quality‐adjusted life‐year (QALY) to $5.2 million/QALY and $8.8 million/QALY . Rather than undertake further cost‐effectiveness, we conducted an analysis of the number of infectious units that would be removed from the system through various testing methods and the cost of prevention.…”

Transfusion-transmitted babesiosis: is it time to screen the blood supply?

“…Each has arrived at different conclusions regarding the cost effectiveness of TTB screening for similar programs. Two studies found that effective programs could be devised that would cost less than the 1 million dollars per QALY threshold [37,48]. One of these found that universal donor antibody screening for B. microti in endemic areas of the US is the most promising approach while the other found that universal PCR in four endemic states would be most cost effective.…”